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NCT Number: NCT02036736

Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring - COGNIDES

The recovery of cognitive and psychomotor functions is best performed under anesthesia after desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.

The principal objective is to compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane) using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory (visual verbal learning test) made SSPI.

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Key information

Conditions

Orthopedic Surgery Total Hip Prosthesis Total Knee Replacement

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Saint Antoine

Paris, 75012, France

About this study

The day before surgery, patients sign the consent and will be randomized. Then 3 tests (Stroop test, Digit Symbol Substitution Task and visual verbal learning test) will be performed. No anxiolysis will be given to the patient. The anesthetic induction will be with IV propofol (2-3 mg / kg). The maintenance will anesthetic, desflurane by for a minimum alveolar concentration of between 2% and 6% or propofol for intravenous anesthesia user target controlled. In SSPI, the Aldrete score will be evaluated every 5min. Upon obtaining a Aldrete score> 8/10, the day before the tests will be carried out again

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years and ≤ 80 years
  • ASA I, II
  • General anesthesia provided
  • Scheduled orthopedic surgery
  • Duration of surgery between one and three hours
  • Patient has given its written consent
  • Patient receiving medical health insurance

Exclusion criteria

  • MMS (Mini Mental State) ≤ 24
  • Patient does not speak or read or do not understand the French
  • Previous surgery within seven days
  • Coronary insufficiency, renal, hepatic
  • Chronic pulmonary disease
  • Obesity (BMI> 35)
  • Addiction
  • Chronic alcoholism
  • Hematocrit <25%
  • Personal and family history of malignant hyperthermia
  • Taking benzodiazepines or psychotropic within 24 hours preoperative
  • Psychiatric pathology being
  • Psychological or neurological disorder causing difficulties in understanding the study
  • Chronic pain and / or taking analgesics 3.
  • Pregnancy or breastfeeding
  • Disorder of hemostasis: platelets <80,000 / mm3, PT <50% TCA> 1.5 times the control.
  • Hypersensitivity to propofol or desflurane or any of the excipients
  • Patients allergic to soy and peanuts
  • History of liver disease, jaundice, unexplained fever, eosinophilia after administration of a halogenated anesthetic
  • Hypersensitivity to egg lecithin.

Treatment and study plan

Intraoperative anesthetic strategy by Propofol

Drug

1- Arm Propofol: Propofol TCI induction target between 2 and 6 mg / mL

  • Sufentanil (0.15 mg / kg intravenously (IV))
  • Atracurium (0.5 mg / kg IV) Maintenance mode by Propofol TCI target between 2 and 4 micrograms / mL tune to 40 <BIS <60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade

Intraoperative anesthetic strategy by Desflurane

Drug

2- Arm Desflurane Desflurane induction (2-3 mg / kg)

  • Sufentanil (0.15 mg / kg IV)
  • Atracurium (0.5 mg / kg IV)) Desflurane closed by maintenance target with minimal alveolar concentration (MAC) to adapt the circuit to obtain a figure 40 <BIS <60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade

Primary outcomes

  1. Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)

    Time frame: 1 day

    Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane), using three tests (Stroop test, Digit Symbol Substitution Task and test verbal memory (visual verbal learning test) made room post-interventional monitoring

    The primary endpoint will be the average score of three tests in room post-interventional monitoring (Stroop test, Digit Symbol Substitution Task, Visual Verbal Learning Test) scores expressed in standard deviation

Secondary outcomes

  1. proportion of patients with nausea and vomiting

    Time frame: 1 day

  2. Search intraoperative factors alterations in cognitive and psychomotor functions (number of red blood cells transfused, number of hypotensive episodes (≤ 80mmHg or MAP NOT ≤ 65mmHg)≥ 10 minutes).

    Time frame: 1 day

  3. Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring

    Time frame: 1 day

  4. Evaluate postoperative pain in room post-interventional monitoring

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring

Acronym: Cognides

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 15, 2014
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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